Gastroenterology
Volume 125, Issue 2 , Pages 421-428, August 2003

Gastric electrical stimulation for medically refractory gastroparesis☆

  • Thomas Abell

      Affiliations

    • University of Mississippi, Jackson, Mississippi, USA
    • ,
  • Richard McCallum

      Affiliations

    • Corresponding Author InformationAddress requests for reprints to: Richard W. McCallum, M.D., University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, Kansas 66160-7350, USA; fax: (913) 588-3975
    • University of Kansas, Kansas City, Kansas, USA
    • ,
  • Michael Hocking

      Affiliations

    • University of Florida, Gainesville, Florida, USA
    • ,
  • Kenneth Koch

      Affiliations

    • Penn State University, Hershey, Pennsylvania, USA
    • ,
  • Hasse Abrahamsson

      Affiliations

    • University of Göteborg, Göteborg, Sweden
    • ,
  • Isabelle LeBlanc

      Affiliations

    • Hospital Charles Nicolle, Rouen, France
    • ,
  • Greger Lindberg

      Affiliations

    • Karolinska Institute, Stockholm, Sweden
    • ,
  • Jan Konturek

      Affiliations

    • Elbe Kliniken Stade, Stade, Germany
    • ,
  • Thomas Nowak

      Affiliations

    • St. Vincent’s Hospital, Indianapolis, Indiana, USA
    • ,
  • Eammon M.M Quigley

      Affiliations

    • National University of Ireland, Cork, Ireland
    • ,
  • Gervais Tougas

      Affiliations

    • McMaster University, Hamilton, Ontario, Canada
    • ,
  • Warren Starkebaum

      Affiliations

    • Medtronic, Inc., Minneapolis, Minnesota, USA

Received 17 September 2002; accepted 15 May 2003.

Abstract 

Background & aims:

This study investigated the efficacy of gastric electrical stimulation for the treatment of symptomatic gastroparesis unresponsive to standard medical therapy.

Methods:

Thirty-three patients with chronic gastroparesis (17 diabetic and 16 idiopathic) received continuous high-frequency/low-energy gastric electrical stimulation via electrodes in the muscle wall of the antrum connected to a neurostimulator in an abdominal wall pocket. After implantation, patients were randomized in a double-blind crossover design to stimulation ON or OFF for 1-month periods. The blind was then broken, and all patients were programmed to stimulation ON and evaluated at 6 and 12 months. Outcome measures were vomiting frequency, preference for ON or OFF, upper gastrointestinal tract symptoms, quality of life, gastric emptying, and adverse events.

Results:

In the double-blind portion of the study, self-reported vomiting frequency was significantly reduced in the ON vs. OFF period (P < 0.05) and this symptomatic improvement was consistent with the significant patient preference (P < 0.05) for the ON vs. OFF period determined before breaking the blind. In the unblinded portion of the study, vomiting frequency decreased significantly (P < 0.05) at 6 and 12 months. Scores for symptom severity and quality of life significantly improved (P < 0.05) at 6 and 12 months, whereas gastric emptying was only modestly accelerated. Five patients had their gastric electrical stimulation system explanted or revised because of infection or other complications.

Conclusions:

High-frequency/low-energy gastric electrical stimulation significantly decreased vomiting frequency and gastrointestinal symptoms and improved quality of life in patients with severe gastroparesis.

Abbreviations:  GES, gastric electrical stimulation, GI, gastrointestinal, HQOL, health-related quality of life, MCS, mental composite score, PCS, physical composite score, TSS, total symptom score

 

☆ Supported in part by Medtronic, Inc., Portions of the study were presented in abstract form at the American Gastroenterological Association meetings in 2001 and 2002.

PII: S0016-5085(03)00878-3

doi:10.1016/S0016-5085(03)00878-3

Gastroenterology
Volume 125, Issue 2 , Pages 421-428, August 2003